Malta: paving the way for cannabis research and development

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Talking about the wider landscape of medicinal cannabis research and development in Malta, John Charles Ellul explains more.

John Charles Ellul serves as Advisor to the office of the Prime Minister in Malta. Attending the MJBiz European Cannabis Symposium in May, he emphasised the importance of the medicinal cannabis market to the island, along with the cannabis research and development.

On 6 May 2019, Health Europa attended the MJBiz European Cannabis Symposium in Copenhagen, Denmark. At the event, a panel led by Alfredo Pascual (International Analyst for Marijuana Business Daily) discussed the future of Cannabis in Europe, with an Advisor to the Office of the Prime Minister in Malta – John Charles Ellul – taking part.

Ellul serves as an Advisor for the Parliamentary Secretary for Reforms, Citizenship and Simplification of Administrative Processes.1 Prior to his involvement in the cannabis industry he served in the army and later the police force, rising through the ranks to the prestigious role of senior inspector specialising in forensic laboratories during a career spanning 13 years and leading to multiple opportunities for him to explore his highly transferrable skills.2

In opening the panel discussion Pascual asked Ellul about the role of Malta in Europe in the wider landscape of medicinal cannabis reform, which he answered: “In Malta, we are looking into two dimensions which are very important –the legal aspect and the social and political perspective. We are combining these two elements in order to make sure that everything we do is to the benefit of the patient and the industry.”

Ellul went onto discuss how companies can become certified in Malta: “This is in the making – it’s a question of being a highly regulated market which needs to meet compliance in line with the highest standards of the pharmaceutical industry. As a result, rushing this would bring pain and damage to the industry. We need to ascertain that everything we are doing; we are doing within the parameters of the law. I think it’s only a matter of time before we see the first producers who will be fully fledged and licensed in Malta.”

Europe: the largest future market

Continuing his contribution Elllul added: “Malta is a very small country, so the investment does not merit the [potential] consumption. The market is intended for beyond our shores, and even the scale of the operations that the investors are looking at are quite considerable. For investors to investigate such considerable investment, it is obvious that the European market has a future of growth, which in my opinion is in the near future. I am sure that other states in the European Union will follow suit, and perhaps we might also have European homogeneity within the European legislation. I see the European market being one of the biggest markets in the future.”

Ellul then went on to address what needs to be solved, and how Malta can achieve this: “The aspect of the lack of knowledge and education of the substance, is a curve that we need to inject more education into in order to remove the elephant from the room which is unnecessary fear of legalisation. Once we manage to tear down that wall, I think it is something that many other countries will follow.”

A unique standing in the industry

Expanding on why Malta already has the ideal framework to build a flourishing medical cannabis industry, Ellul added “as it has been said, expertise is one of the most important and critical aspects, but it needs to align with the expertise of the European pharmaceutical industry. Malta is very well aligned – the pharmaceutical industry is one of the biggest industries in Malta. The investment is only a question of whether you have a local operator who has already got everything required to start up and see the company grow, or to align with a foreign company, acquire a brand name and synergise to have something on the market.

“Again, in the first move, advantage plays a huge role in this business. The way the market is being shaped, and the way the market is being developed in such a way, I think there is room for quite a good number of players. The industry will not be restricted to a small number of players, so it therefore depends on how creative the formulations can be, how strong the research is, and the investment into research and development. I think these aspects will be a game changer in this industry.

“I also think there are two facets to this story – one is providing the impulse of the need for THC and all the other formulations that come with this, and then the specifics of having those targeted formulations which can be prescribed for a specific reason. When you look at these two together then the competition will start shaping itself in such a way that obviously those who put the most into research and development, will have a unique standing in the industry.”

Collaboration across Europe

Continuing, Pascual went onto ask Ellul “When you want to get a pharmaceutical expert to work in a cannabis company, do you need to pay more than the pharmaceutical industry to get the best people, or do you find that they actually want to do something new and exciting?” Ellul responded with: “It is a sparse resource, let’s put it that way. This level of expertise is not available off the shelf. Finding a person with the necessary ingredients and qualifications is very important and it is [like finding] a jewel in the industry. In Malta, we cannot boast that we have an abundance of this resource, but the limited resources that we do have [are people] who are very highly qualified and specialised in this field.

“We have the luxury of knowing each other in the industry, and perhaps this pooling or sharing of resources facilitates the operators in Malta. Obviously, the more the numbers grow, it might require importing expertise or experts from Denmark for example. This is something in the equation where there is room for anyone to play in this industry, and we see our professions moving to other countries abroad, and professions and foreigners coming to Malta to work in the industry for the same reason.

“The mobility of human resources now is no longer a concern, unless you need your own homegrown expertise. Obviously having your own, is an advantage because it gives you more flexibility but there’s no restriction in having more as it is creating opportunities for whoever is in this industry” he concluded.

The current legal situation in Malta

The medical cannabis industry is regulated by the Production of Cannabis for Medicinal and Research Purposes Act which came into effect on April 17 2018. The Act describes cannabis as:

  1. Fresh or dried cannabis;
  2. Cannabis oil;
  3. Cannabis plant or seeds;
  4. Derivatives of cannabis; and, or
  5. Any substance and, or product set out in guidelines issued by the regulatory authority to be used exclusively for manufacturing of products for medical use.3

The legislation introduced “the possibility of producing cannabis in Malta however, such production is limited solely to medicinal and research purposes within a regulated and controlled environment. It accentuates that no form of cultivation, importation or processing of cannabis and no production or trade of any products intended for medicinal and/or research purposes deriving from or resulting from the use of cannabis shall be carried out in Malta unless all the necessary approvals, authorisations, licences and, or permits are granted by the Medicines Authority.

“Furthermore, a manufacturing company operating in Malta within the medicinal and research cannabis space, needs to satisfy the Good Manufacturing Practices (‘GMP’) requirements. These requirements are mainly concerned with production and quality control. Applicants are also required to comply with the Production of Cannabis for Medicinal and Research Purposes (Fees) Regulations, (the ‘Fees Regulation’). The Fees Regulation states that the Medicines Authority shall receive the specified fees, from persons intending to apply to carry out importation, wholesale distribution, cultivation and processing, and/or production of cannabis for medicinal use and/or research purposes.4

References

  1. https://mjbizconference.com/speaker/john-charles-ellul/
  2. https://www.maltachamber.org.mt/en/john-charles-ellul—the-ceo-has-to-carry-a-dream-and-be-a-driver-for-change
  3. http://justiceservices.gov.mt/DownloadDocument.aspx?app=lp&itemid=28891&l=1
  4. https://www.fff-legal.com/the-production-of-cannabis-for-medicinal-and-research-purposes-in-malta/
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